Methadone Expansion in Detention Though the Hospital/Clinic Designation (MED)

Evaluating a Novel Approach to Dispensing Methadone in Carceral Facilities

The goal of this clinical trial is to improve implementation of hospital/clinic methadone in several carceral systems and study the effects of implementation on patient outcomes.

This study has four Aims:

• Evaluate an intervention for carceral staff that will receive individual coaching and group didactic sessions focused on improving adoption and implementation of hospital/clinic methadone. Effects of this intervention will be measured via qualitative interviews and baseline, midpoint and final surveys of participants.
• Apply a trial emulation approach to electronic health records from three prison systems currently using hospital/clinic methadone to evaluate the effect of implementation on the initiation and retention of medications for opioid use disorder treatment.
• Link Medicaid data to electronic health records from one prison system implementing hospital/clinic methadone to examine the effect of implementation on post-release outcomes, including MOUD use and broader healthcare utilization.
• Examine the cost effectiveness and budgetary impact of implementing hospital/clinic methadone.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder; Incarcerated Individuals; Methadone Maintenance
• Intervention / Treatment: Other: Learning Collaborative

Detailed Description

Incarcerated persons have a high prevalence of opioid use disorder (OUD), and risk of fatal and nonfatal overdose surges immediately following release. Providing medications for OUD (MOUD) during and following incarceration is a proven strategy for reducing overdose risk, yet few facilities offer MOUD. Of the three MOUDs approved by the Food and Drug Administration, methadone is particularly challenging for carceral facilities to provide because it typically can be dispensed only by federally-accredited and certified opioid treatment programs (OTPs). Very few carceral facilities have created onsite OTPs, citing the costly, time-intensive process as a barrier to uptake. Other facilities do not provide methadone or offer limited methadone through partnerships with community-based OTPs. This is often not feasible in rural areas without OTPs, where many carceral facilities are located. Expanding access to carceral methadone is of key public health importance, because it is the optimal treatment for some patients, particularly those with high opioid tolerance associated with use of fentanyl and its analogs.

In 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) released updated 42 CFR Part 8 rules, which clarified that any carceral facility registered as a "hospital/clinic" with the Drug Enforcement Administration (DEA) is permitted to stock and dispense methadone for the treatment of OUD, as long as the patient is primarily being treated for another medical condition. Given the high prevalence of comorbidities and the opportunity to provide methadone outside of OTPs, the hospital/clinic designation could dramatically expand access to MOUD for incarcerated persons. However, implementation also requires carceral systems to engage with potentially unfamiliar processes, such as applying for the hospital/clinic designation, stocking and dispensing methadone, and initiating and maintaining methadone treatment. Through a technical assistance partnership with our team, three state departments of corrections (DOCs) - Colorado, Delaware, and Washington - are the first jurisdictions to implement the hospital/clinic designation for this purpose, each at different stages of implementation. Given the recency of the hospital/clinic designation rules, there is need to understand how these vanguard DOCs are implementing, how adoption affects OUD-related outcomes during and after incarceration, and the cost-effectiveness of this process, all of which can inform future adoption of this novel approach for methadone provision.

Working in partnership with these vanguard DOCs, the overarching goal of this five-year JCOIN project is to generate research evidence that can support the broader implementation of methadone in carceral facilities using the hospital/clinic designation. We will conduct a mixed-methods study that engages early adopter facilities in a learning collaborative that will blend didactic education and applied problem-solving, evaluating implementation outcomes via surveys and qualitative interviews (Aim 1). We will use 2022-2028 carceral health records from all three vanguard DOCs to study OUD-related outcomes during incarceration (Aim 2). We will link carceral health records with post-release Medicaid data in the Washington DOC to examine post-release OUD outcomes (Aim 3) and conduct a cost-effectiveness evaluation (Aim 4). Our study is guided by the substance use treatment framework, the Behavioral Cascade of Care, and the implementation outcomes framework, RE-AIM. Our study aims are as follows:

Aim 1: Engage early implementers in a learning collaborative to improve reach, adoption, and implementation of the hospital/clinic designation. Hypothesis: The learning collaborative will improve the reach and adoption of methadone via the hospital/clinic designation and help navigate potential challenges, such as stigma towards MOUD, establishing methadone stocking and dispensing protocols, staffing, reentry planning and coordination between security and medical staff.

Aim 2: Identify the effect of the hospital/clinic designation on initiation and retention for MOUD treatment during incarceration. Hypothesis: The hospital/clinic designation will result in improved overall initiation and retention of MOUD in the Colorado, Delaware and Washington DOCs.

Aim 3: Examine the effect of the hospital/clinic designation on post-release care for opioid use disorder and chronic health conditions. Hypothesis: Use of the hospital/clinic designation will result in improved post-release use of methadone and chronic condition management, and decreased incidence of overdose in the year following release. Effects will vary by reentry county characteristics.

Aim 4: Calculate the cost, cost-effectiveness, and budgetary impact of carceral methadone treatment delivered via the hospital/clinic designation. Hypothesis: Use of the hospital/clinic designation will be cost-effective and affordable within the resources of each DOC compared to the status quo where methadone is only obtained from OTPs.

Study results will inform decisions about current and future adoption of this important new option for expanding methadone access in carceral facilities, with the potential to have huge lifesaving effects on a marginalized population.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brendan Saloner, PhD; Phone Number: 401-863-2228; Email: brendan_saloner@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Employee of a carceral system interested in or implementing the hospital/clinic designation
• Involved in security, medical, or budget/administrative aspects of the carceral system

Exclusion Criteria:

• Does not meet inclusion criteria above

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Learning Collaborative; All participants will receive individual and group coaching sessions	Other: Learning Collaborative; All participants will receive individual and group coaching sessions to facilitate implementation of the hospital/clinic designation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients on methadone through h/c	Number of patients receiving methadone via the hospital/clinic designation	At baseline, at month 12, and at month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation outcomes assessment	Implementation Outcomes Assessment from Weiner et al., 2017. doi:10.1186/s13012-017-0635-3. The three measures from this assessment will be combined into one measure.	At baseline, at month 12, and at month 24
Staff Attitudes Towards MOUD	Knudsen et al., 2005's Staff Attitudes Towards MOUD measure. doi:10.1016/j.jsat.2005.05.002	At baseline, at month 12, and at month 24
Organizational Readiness for Implementing Change	Shea et al., 2014's Organizational Readiness for Implementing Change measure. doi:10.1186/1748-5908-9-7	At baseline, at month 12, and at month 24

Collaborators and Investigators

• Sponsor: Brendan Saloner
• Collaborators: National Institute on Drug Abuse (NIDA); Washington University School of Medicine; Johns Hopkins Bloomberg School of Public Health; Brown University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: STUDY00000987; R01DA064510 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For participants who consent to data sharing, de-identified survey and interview data will be deposited into the HEAL data repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No